Mintz Levin - Health Law & Policy Matters

Behind the Curtain: Shkreli was NOT the Big Story on the Hill Today

Congress’s complex relationship with prescription drugs was on display today in the House of Representatives. In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing…more
| Consumer Protection, Elections & Politics, Health, Science, Computers, & Technology

Latest OCR Enforcement Action: Underbed Storage is Not Appropriate for PHI

Recent enforcement actions by the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) have highlighted that, not surprisingly, Covered Entities should not leave medical records in a physician’s…more
| Administrative Law, Civil Procedure, Consumer Protection, Health, Privacy

Telemedicine Momentum Picking up Steam as New Legislation Introduced in U.S. Senate

On February 3, 2016, a bipartisan group of Senators led by Senator Brian Schatz (D-HI) and Senator Roger Wicker (R-MS) have unveiled legislation that would expand the use of telemedicine and remote patient monitoring under…more
| Elections & Politics, Health, Science, Computers, & Technology

ICYMI: Biosimilars and FDA Regulatory Webinar

Our Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation. Linda and Joanne discussed statutory provisions related to FDA’s authority to approve…more
| Consumer Protection, Science, Computers, & Technology

FDA Releases Draft Guidance for Medical Device Cybersecurity

It seems that everything in our life is getting connected to the Internet. We now live in an age where household items like refrigerators have Internet-connected LCD screens and privacy experts talk about the so-called “Internet…more
| Consumer Protection, Privacy, Health, Science, Computers, & Technology

The Challenge of Non-Interference

To understand the policy challenge created by repeal of the non-interference clause, consider this simple example. Acme Drug Company brings a drug to the market as a single source innovator. Essentially, they are without…more
| Health, Science, Computers, & Technology

CBO’s Budget Forecast and the Silver Tsunami

This week, the Congressional Budget Office (CBO) released a projection that shows Medicare enrollment will grow by more than 30 percent in the next decade alone, and the number of seniors will steadily grow from 55 million today…more
| Health

Massachusetts Health Care Reform – Full Speed Ahead; Health Policy Commission 2015 Cost Trends Report

The Massachusetts Health Policy Commission (HPC) has issued its 2015 Cost Trends Report, based on the HPC’s annual health care cost growth hearings. The report contained 13 key recommendations across a wide range of health care…more
| Health

Safety of Both Devices and Drugs Need to Be Better Tracked, FDA Hears from Oversight Bodies

FDA lacks the appropriate data to effectively conduct postmarket surveillance and safety tracking activities, according to two reports released earlier this month. First, Senator Patty Murray’s Health, Education, Labor, and…more
| Consumer Protection, Elections & Politics, Health, Science, Computers, & Technology

Senate Working Group Considers Telehealth Policy Changes to Medicare

In keeping with the boom of telehealth legislation introduced last year at both the state and federal level, the Senate Finance Committee is considering several policy changes that, if ultimately enacted, could make telehealth…more
| Elections & Politics, Health, Science, Computers, & Technology

A New Year’s Resolution: Avoid The Rising Tide of Defamation Claims In The Health Care Arena

In college and graduate school, we all had professors that had “non-attribution/academic freedom” policies designed to foster open debate, critical thinking and robust discussion. To state the obvious, we are a long way from…more
| Civil Procedure, Communications & Media Law, Constitutional Law, Health, Science, Computers, & Technology

Gun Control: HIPAA Final Rule Targets Background Checks and Mental Health Reporting

President Obama has announced plans to tighten gun control regulations, including applying the background check requirement to dealers at gun shows and on websites. Federal law already requires that those “engaged in the…more
| Constitutional Law, Elections & Politics, Health, Privacy

The Managed Care Industry – 2015 Year in Review

As we start a new year, let’s take a look back at a few hot topics that emerged in the managed care industry in 2015 and will likely be drivers of developments in 2016. Industry Consolidation – The Changing Landscape…more
| Antitrust & Trade Regulation, Health, Mergers & Acquisitions

Laboratories – 2015 Year in Review [VIDEO]

Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory developed…more
| Government Contracting, Health, Science, Computers, & Technology

A Return to Evanston: FTC Revisits Old Ground in Yet Another Hospital Merger Challenge

Last week, the Federal Trade Commission (“FTC” or “Commission”) authorized staff to file an administrative complaint and to seek in federal court a temporary restraining order and a preliminary injunction to block the proposed…more
| Administrative Law, Antitrust & Trade Regulation, Consumer Protection, Health, Mergers & Acquisitions
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